MHI-TM2000 Linear Accelerator System, VERO, Imavis— 510(k) K152867
Substantially EquivalentMitsubishi Heavy Industries, Ltd.
FDA 510(k) clearance K152867 for MHI-TM2000 Linear Accelerator System, VERO, Imavis, Substantially Equivalent on 2015-10-21. Applicant: Mitsubishi Heavy Industries, Ltd.. Device class: 2.
Clearance details
- Applicant
- Mitsubishi Heavy Industries, Ltd.
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hiroshima-Shi, JP
Recent devices under product code IYE
view allMore clearances from Mitsubishi Heavy Industries, Ltd.
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K152867
K-number listed on FDA's recall record- Z-1585-2018 — MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
- Z-1308-2016 — VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
- Z-1244-2016 — MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152867.
Data sourced from openFDA. This site is unofficial and independent of the FDA.